Preparing for the next decade of anti-VEGF biosimilars for retinal diseases: a focus on South Asia

ABSTRACT

Introduction

South Asian countries such as India, South Korea, and Japan have played a key role in spearheading the research and development of biosimilars of the anti-vascular endothelial growth factor (anti-VEGF) ranibizumab for retinal diseases. It is important to understand how this region is preparing for the next decade in the field of anti-VEGF biosimilars for retinal diseases.

Areas covered

We discuss the existing anti-VEGF ranibizumab biosimilars along with the biosimilars that might receive approval in the coming decade. Furthermore, we discuss the development status of aflibercept biosimilars that might receive approval as soon as the aflibercept patent expires.

Expert opinion

The South Asian region seems to be well prepared, with multiple ranibizumab and aflibercept biosimilars in the pipeline. However, it has to be seen whether these therapies will have widespread global clearance or will simply obtain approval from the Asian regional authorities.

KEYWORDS:

• Biosimilars
• anti-VEGF
• retina
• South Asia
• ranibizumab
• aflibercept
• ophthalmology

Article highlights

• South Asia is a key driver in the research and development of anti-VEGF biosimilars for retinal diseases

• At least two more ranibizumab biosimilars and five aflibercept biosimilars are in the final stages of their development in the South Asian region

• Approval of Aflibercept biosimilars in the next decade might play a significant role in retina practice in South Asia

• Anti-VEGF biosimlars in the next decade might improve access to this treatment by lowering the cost significantly in this region

Declaration of interest

A Sharma has acted as a consultant for Novartis, Allergan, Bayer and Intas. A Loewenstein reports involvement with Allergan, Novartis, Roche, Notal Vision, Forsightslabs, Beyeonics and Bayer Health Care. F Bandello has acted as a consultant for Allergan, Bayer, Boehringer- Ingelheim, Fidia Sooft, Hofmann La Roche, Novartis, NTC Pharma, Sifi, Thrombogenics and Zeiss. BD Kuppermann has performed clinical research for Alcon, Alimera, Allegro, Allergan, Apellis, Clearside, Genentech, GSK, Ionis, jCyte, Novartis, Regeneron and ThromboGenics, and has acted as a consultant for Alimera, Allegro, Allergan, Cell Care, Dose, Eyedaptic, Galimedix, Genentech, Glaukos, Interface Biologics, jCyte, Novartis, Ophthotech, Regeneron, Revana and Theravance Biopharma. BD Kuppermann also acknowledges an unrestricted grant from Research to Prevent Blindness to the Gavin Herbert Eye Institute at the University of California, Irvine. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

A reviewer on this manuscript has acted as a speaker for Coherus and Biogen (U.S.A.). Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Acknowledgments

BD Kuppermann acknowledges an unrestricted grant from Research to Prevent Blindness to the Gavin Herbert Eye Institute at the University of California, Irvine. We would like to acknowledge Ridhi Sharma from the University of Michigan, Michigan, USA for English Language proofing during revision.

Author contributions

A Sharma: conception, analysis, drafting, integrity check, final approval. N Kumar, N Parachuri, A Loewenstein, F Bandello, BD Kuppermann: drafting, revision, analysis, integrity check.

Additional information

Funding

This paper was not funded.